Recruiting

Integrative Pain Management

Sponsor:

UCLA

Code:

NCT06327542

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Group Acupuncture

Integrative Group Medical Visits

Study Details

Brief summary:

Socioeconomically disadvantaged populations have a high prevalence of chronic pain, exacerbated by social isolation, intersectional stigma, and disparities in pain assessment and treatment options. Effective interventions using a multilevel, biopsychosocial approach are needed to decrease the unequal burden of pain. The proposed study will test group-based integrative models of pain management in primary care safety net clinics to improve pain care for racially and ethnically diverse low-income patients.

Conditions

Chronic Pain

Study ID

NCT06327542

Start date

Jul 12, 2024

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults aged ≥ 18
  • Fluency in English or Spanish
  • Panelled to a primary care provider at one of the study clinics
  • Diagnosis of chronic pain (> 3 months)
  • Had a primary care visit for chronic pain within the past six months
  • Ability to provide a phone number
  • Able to participate in groups
  • Intent to be available for up to 24 weeks

Exclusion Criteria:

  • Received group-based pain management in the past 3 months
  • Received acupuncture treatment for pain in the past 3 months
  • Active cancer treatment
  • Inability to provide informed consent due to mental illness or cognitive impairment

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Usual Care

Participants will receive care as usual provided through their primary care providers. Usual care includes medical diagnostic evaluation, analgesic drug therapies, recommendations for physical activity, and sometimes referral to specialist physicians or physical therapy. Usual care was chosen as a comparison arm for this study because it is practical and clinically relevant. Participants randomized to usual care will be put on a waitlist and can access group acupuncture or IGMV after their final study visit.

experimental: Group Acupuncture

Participants randomized to acupuncture will receive 12 weeks of acupuncture treatments delivered in a group setting, dosing similar to prior research. Acupuncture point selection and other treatment details will follow responsive manualization, a protocol developed for the largest clinical trial of group acupuncture to date. A licensed acupuncturist experienced with administering group acupuncture treatments will determine each participant's traditional Chinese medicine diagnosis and administer 8-10 acupuncture needles on distal points of participant's body (below the knees, from the elbows to the hands, and on the head). Duration of assessment, needle placement and retention will be 30-45 minutes. Details of acupuncture treatments (e.g., frequency and duration, traditional Chinese medicine diagnosis, number of needles and points used) will be documented in electronic health records.

experimental: Integrative Group Medical Visits (IGMV)

IGMV will consist of a 12-week program that provides education on the biopsychosocial model of pain and multimodal treatments; physical movement; mindfulness training; and peer support. Non-pharmacologic approaches are based on guidelines on chronic pain management; feedback of experts, staff, and patients; and feasibility with the greatest potential to benefit participants. Participants will receive a binder with educational materials.

experimental: Group Acupuncture and IGMV

Both group acupuncture and IGMV. Along with usual care, participants will be offered weekly group acupuncture treatments and integrative group medical visits as described above.

Interventions

Group Acupuncture

Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles.

Integrative Group Medical Visits

IGMV sessions will be weekly for 90-120 minutes in a group meeting space. Sessions will start with a "check-in" where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice.

Primary outcome measure

  • Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function. [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
  • Change in Social support and Pain Questionnaire (SPQ) [ Time Frame: Baseline, 12 weeks, and 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

Tom Waddell Urban Health Clinic

Recruiting

San Francisco, California, United States, 94102

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • health equity
  • integrative health
  • nonpharmacologic pain management
  • stigma
  • social isolation
  • primary care
  • group medical visits

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-11.